More Action Needed to Address Canadian Drug Shortages

24 July 2012

Toronto -

The Canadian Cancer Society is concerned about continuing drug shortages in Canada and has developed an action plan with recommendations that they believe would effectively address the situation. The Society is urging the federal government to adopt and implement its plan.

The primary recommendation is that there must be one agency – Health Canada – responsible for:

“When addressing a complex national problem that involves many stakeholders one entity must coordinate a response,” says Paul Lapierre, Vice President, Public Affairs and Cancer Control, Canadian Cancer Society. “Health Canada must take the lead and work closely with healthcare professionals, patient groups, manufacturers and other levels of government to address drug shortages before they become worse and more patients are affected.”

The Society strongly believes that any plan to address drug shortages must focus on the needs of patients.

“Patients must have access to an uninterrupted supply of required medication in a timely manner, without financial hardship,” says Dan Demers, Director, Public Issues, Canadian Cancer Society. “It’s not acceptable for patients who are already going through a difficult time to have to worry about obtaining drugs they need for their treatment.”

Drug shortfalls have been occurring more frequently in the last two to three years, both in Canada and around the world. Most recently, cancer patients were affected by the production slow down at Quebec-based drug manufacturer Sandoz Canada. The shortages caused by this slow down were particularly concerning for cancer patients as Sandoz supplies about 90% of the injectable drugs used in Canada, particularly pain-management medication, and is a leading supplier of generic cancer medication and supportive drugs.

The Canadian Cancer Society’s Drug Shortage Action Plan

Our position

The Canadian Cancer Society believes that cancer patients must have access to high-quality, timely care, no matter where they live in Canada.The Canadian Cancer Society believes that any plan to address drug shortages must focus on the needs of patients. Patients must have access to an uninterrupted supply of required medication in a timely manner, without financial hardship.

Primary recommendation

There must be one agency – Health Canada – responsible for:

overseeing efforts to prevent drug shortages from occurring in the first place

providing leadership and coordinating a response when shortages occur

providing regular, substantial and clear updates to Canadians on these ongoing efforts

Health Canada must work closely with healthcare professionals, patient groups, drug manufacturers and other levels of government to prevent and minimize the impact of shortages.

Health Canada is the regulator of drugs – it approves and certifies drugs for sale, monitors their safety, sets maximum prices and regulates the way drug companies can operate.

Recommendations to prevent shortages

Health Canada, in conjunction with the provincial and territorial governments, group purchasing organizations and industry, must investigate and address the various causes of drug shortages to prevent future occurrences.

The drug manufacturing and supply industry must make every effort to prevent shortages from occurring and work to minimize their impact when they do occur. This includes a commitment to openness, transparency and timely communication of information. The Society recognizes the economic pressures and manufacturing constraints on producers; however, patients must be the first priority.

Drug shortages have a variety of causes, including a shortage of raw ingredients, manufacturers’ and suppliers’ business decisions and production shutdowns. However, in some cases, shortages can be made worse by the type of purchasing contract negotiated. The Society acknowledges that drug purchasing is a sliding scale. At one end, single sourcing is likely to reduce costs because drugs have been bought in bulk, but it could increase the chances of a shortage if the sole supplier cannot meet its obligations. At the other end, a drug that is supplied by a diversity of suppliers lessens exposure to shortages, but may lead to increased drug costs. The Society believes the solution lies in a balanced approach to this scale.

If purchasers choose to source drugs from a single source, the Society recommends the inclusion of additional safeguards, such as requiring manufacturers to guarantee supplies as a condition of sale and naming a backup source if necessary. In addition, as is the case in New Zealand, manufacturers would absorb any additional cost should this backup source be required.

In addition, Health Canada must work with provincial and territorial governments to review purchasing contracts of critical medicines to identify contracts with one supplier so that alternative suppliers could be sought.

Recommendations for managing shortages

When drug shortages arise, Health Canada, the provinces and territories, group purchasing organizations and drug manufacturers must take additional steps, including:

Health Canada must coordinate themanagement of drug shortages to prevent them escalating. This includes:

asking domestic producers to increase production where possible

fast-tracking safe, effective and comparable replacement medication for the duration of the shortage

Drug manufacturers must notify Health Canada six months in advance of a product discontinuation, as in the United States.

Drug manufacturers must notify Health Canada of any anticipated product shortage as soon as they become aware of the possibility.

All parties must commit to openness and transparency by providing clear and accurate information at regular intervals to patients and healthcare professionals about the reason for the shortage, the estimated duration of the shortage and replacement medications available to them that meet the equivalent patient outcome.

Access to medication is paramount and should comewith no additional costs to patients as a result of switching medications due to a shortage. Where feasible, there should be no additional cost to payers.

Ensuring that replacement medication is fairly distributed as it reaches market.

If Health Canada expedites the approval or import of replacement medication, all payers should take immediate steps to ensure interim coverage until the original product is once again available.

The Canadian Cancer Society is a national community-based organization of volunteers whose mission is the eradication of cancer and the enhancement of the quality of life of people living with cancer. When you want to know more about cancer, visit our website www.cancer.ca or call our toll-free, bilingual Cancer Information Service at 1 888 939-3333.